Pituitary AdenomaHyp'OpNCT06053437
Prognostic Indicators in Pituitary Adenoma Surgery: a Comprehensive Analysis of Surgical Outcomes and Complications.
An observational study of Pituitary Adenoma and Surgery-Complications, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Predicting the outcome of pituitary surgery, particularly the risk of complications, is a critical determinant in selecting the appropriate treatment modality for patients. To date, only a limited number of risk factors have been identified for complications following pituitary surgery, including tumor size, younger… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Adenoma, Surgery-Complications
- How many people
- 211 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients having undergone transsphenoidal pituitary surgery at Nancy University Hospital (France) between 2012 and 2022 for a pituitary adenoma are to be included.
Who may be able to join
- Transsphenoidal pituitary surgery at Nancy University Hospital (France) between 2012 and 2022 for a pituitary adenoma.
Who cannot join
- No 4 month evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Predicting the outcome of pituitary surgery, particularly the risk of complications, is a critical determinant in selecting the appropriate treatment modality for patients. To date, only a limited number of risk factors have been identified for complications following pituitary surgery, including tumor size, younger age, and previous surgical intervention. Furthermore, existing studies have demonstrated that prolactin levels can serve as a surrogate marker for assessing pituitary function, specifically revealing associations between elevated prolactin levels and anterior pituitary insufficiencies.
In a retrospective study on the "HYP'OP" cohort, the aim of the study is to identify predictive factors for both surgical outcomes and complications.
- Conditions
- Pituitary Adenoma, Surgery-Complications
- Keywords
- transsphenoidal surgery, pituitary adenoma, post-operative complications
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hyp'Op Cohort | The 'HYP'OP' cohort comprises patients who underwent endoscopic endonasal surgery (EES) for pituitary adenoma during a 10-year period spanning from January 2012 to June 2022 at the Nancy University Hospital. Post-operative hospitalization in our endocrinology department is part of the standard care protocol, which also includes a systematic reevaluation 4 -6 months following the surgical intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors associated with complications
Risk factors associated with complications arising from surgery, specifically targeting the incidence of de-novo, clinically significant pituitary insufficiencies
Measured: Within 6 months after surgery
Secondary outcomes (2)
Factors predictive of the 'success' of surgery
Patients were stratified into groups based on surgical indications. The first group consisted of non-secreting, non-compressive adenomas without preoperative insufficiency or hyperprolactinemia, with success defined as absence of new insufficiency and no MRI-detected residual tissue. The second group was similar to the first but included disconnection hyperprolactinemia, and success was defined by the absence of new insufficiency and hyperprolactinemia regression. The third group involved non-secreting adenomas with at least one preoperative axis deficiency, irrespective of hyperprolactinemia, with success defined as restoration of at least one deficient axis without new insufficiency. The fourth group included secreting adenomas, with success defined as hypersecretion regression. The fifth group involved adenomas operated on for their compressive effect on the optic pathways, with or without hyperprolactinemia, and success was defined as no compression observed on follow-up MRI.
Measured: Within 6 months after surgery
Is immediate postoperative hypoprolactinemia predictive of the onset of a new, clinically significant hormonal insufficiency?
patients were stratified into four groups based on immediate postoperative prolactin levels: Group 1 consisted of severe hypoprolactinemia; Group 2 included moderate hypoprolactinemia; Group 3 involved normal prolactin levels, defined by prolactin levels between 5 and 20 ng/ml; and Group 4 comprised hyperprolactinemia, defined by prolactin levels > 20 ng/ml. It should be noted that these instances of hyperprolactinemia are theoretically all disconnection hyperprolactinemias, as patients with lactotroph adenomas were excluded from this analysis. Patients under treatment for hyperprolactinemia were also excluded.
Measured: Within 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Feb 2023
- Primary completion15 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DEMARQUET Lea, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053437
- Sponsor's protocol ID
- 2022PI198
- Acronym
- Hyp'Op
- Status last verified
- Sep 2023
- First submitted
- 3 Feb 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riley G, Scheyer N, Klein M, Merlot I, Guerci B, Jeanbert E, Demarquet L. Prognostic indicators in pituitary adenoma surgery: a comprehensive analysis of surgical outcomes and complications. Front Endocrinol (Lausanne). 2024 Jan 11;14:1327404. doi: 10.3389/fendo.2023.1327404. eCollection 2023.
PubMed 38274233
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Indicators in Pituitary Adenoma Surgery: a Comprehensive Analysis of Surgical Outcomes and Complications.
- ClinicalTrials.gov ID
- NCT06053437
- Acronym / sponsor ID
- Hyp'Op / 2022PI198
- Conditions
- Pituitary Adenoma, Surgery-Complications
- Keywords
- transsphenoidal surgery, pituitary adenoma, post-operative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Predicting the outcome of pituitary surgery, particularly the risk of complications, is a critical determinant in selecting the appropriate treatment modality for patients. To date, only a limited number of risk factors have been identified for complications following pituitary surgery, including tumor size, younger age, and previous surgical intervention. Furthermore, existing studies have demonstrated that prolactin levels can serve as a surrogate marker for assessing pituitary function, specifically revealing associations between elevated prolactin levels and anterior pituitary insufficiencies.
In a retrospective study on the "HYP'OP" cohort, the aim of the study is to identify predictive factors for both surgical outcomes and complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyp'Op Cohort | – | –The 'HYP'OP' cohort comprises patients who underwent endoscopic endonasal surgery (EES) for pituitary adenoma during a 10-year period spanning from January 2012 to June 2022 at the Nancy University Hospital. Post-operative hospitalization in our endocrinology department is part of the standard care protocol, which also includes a systematic reevaluation 4 -6 months following the surgical intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients having undergone transsphenoidal pituitary surgery at Nancy University Hospital (France) between 2012 and 2022 for a pituitary adenoma are to be included.
Key inclusion criteria (1 listed)
- Transsphenoidal pituitary surgery at Nancy University Hospital (France) between 2012 and 2022 for a pituitary adenoma.
Key exclusion criteria (1 listed)
- No 4 month evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk factors associated with complications
Time frame: Within 6 months after surgery
Risk factors associated with complications arising from surgery, specifically targeting the incidence of de-novo, clinically significant pituitary insufficiencies
2 secondary outcomes
Factors predictive of the 'success' of surgery
Time frame: Within 6 months after surgery
Is immediate postoperative hypoprolactinemia predictive of the onset of a new, clinically significant hormonal insufficiency?
Time frame: Within 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 38274233Riley G, Scheyer N, Klein M, Merlot I, Guerci B, Jeanbert E, Demarquet L. Prognostic indicators in pituitary adenoma surgery: a comprehensive analysis of surgical outcomes and complications. Front Endocrinol (Lausanne). 2024 Jan 11;14:1327404. doi: 10.3389/fendo.2023.1327404. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Pituitary Adenoma
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma
RecruitingEarly Phase 1
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
Cushing Disease, Pituitary Adenoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Adenoma and Surgery-Complications, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors associated with complications (time frame: Within 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06053437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.